Regulatory Open Forum

Hi Arjulla,
We have submitted quite a few of these for companies and it's great that you have a breakthrough device!  Honestly, one of the biggest pros is the press that is associated if the designation is granted.  If you are looking for investors, this can be a big advantage when you say "even FDA agrees that we are breakthrough!"   While FDA is not claiming that they have evaluated your technology, it does make it sound like they are giving it a slight  'nod' of approval...that this really could improve patients' lives. I have also spoken to reimbursement consultants who say that having the designation also helps improve the company's case with CMS post-approval (if you do a PMA) or post-granting (if you do a de novo).  The other pros are listed in the guidance that @Loganathan Kumarasamy attached...e.g. sprint discussions and being able to submit additional info to ​a pre-sub after it's sent.

Cons used to be that you would have more people at FDA looking at your file.  A complaint was that having breakthrough designation would actually slow things down as sometimes more reviewers meant more questions.  I haven't seen this since FDA revamped the program.

With regard to submission timing, you can submit whenever during your process EXCEPT after you get approval (of course).  I had a client who asked "thanks for getting us through our submission, can we now submit a breakthrough request?" Nope!

There is some strategy to think about on timing and whether you should do a pre-sub first and then the breakthrough...or breakthrough first.  Feel free to email me and I'm happy to give you some more free tips off line.

Best of luck!

Allison

Hi Arjulla,
We have submitted quite a few of these for companies and it's great that you have a breakthrough device!  Honestly, one of the biggest pros is the press that is associated if the designation is granted.  If you are looking for investors, this can be a big advantage when you say "even FDA agrees that we are breakthrough!"   While FDA is not claiming that they have evaluated your technology, it does make it sound like they are giving it a slight  'nod' of approval...that this really could improve patients' lives. I have also spoken to reimbursement consultants who say that having the designation also helps improve the company's case with CMS post-approval (if you do a PMA) or post-granting (if you do a de novo).  The other pros are listed in the guidance that @Loganathan Kumarasamy attached...e.g. sprint discussions and being able to submit additional info to ​a pre-sub after it's sent.

Cons used to be that you would have more people at FDA looking at your file.  A complaint was that having breakthrough designation would actually slow things down as sometimes more reviewers meant more questions.  I haven't seen this since FDA revamped the program.

With regard to submission timing, you can submit whenever during your process EXCEPT after you get approval (of course).  I had a client who asked "thanks for getting us through our submission, can we now submit a breakthrough request?" Nope!

There is some strategy to think about on timing and whether you should do a pre-sub first and then the breakthrough...or breakthrough first.  Feel free to email me and I'm happy to give you some more free tips off line.

Best of luck!

Allison